1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
imRex Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
3Complaint and recall handling
The written procedures for recalls were inadequate.
4Other quality system
The assessment to release finished products was inadequate.
5Complaint and recall handling
Investigations into deviations, reports, and/or follow-up actions were inadequate. The quality control department did not ensure a thorough investigation and/or evaluation of complaints concerning potentially defective products.
6Stability and storage
The temperature and/or humidity control was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-08-01. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
